Bladeless optical obturator

ABSTRACT

The invention is directed to a bladeless trocar obturator to separate or divaricate body tissue during insertion through a body wall. In one aspect, the obturator of the invention comprises a shaft extending along an axis between a proximal end and a distal end; and a bladeless tip disposed at the distal end of the shaft and having a generally tapered configuration with an outer surface, the outer surface extending distally to a blunt point with a pair of side sections having a common shape and being separated by at least one intermediate section, wherein each of the side sections extends from the blunt point radially outwardly with progressive positions proximally along the axis, and the shaft is sized and configured to receive an optical instrument having a distal end to receive an image of the body tissue. With this aspect, the tapered configuration facilitates separation of different layers of the body tissue and provides proper alignment of the tip between the layers. The side sections include a distal portion and a proximal portion, the distal portion of the side sections being twisted radially with respect to the proximal portion of the side sections. The intermediate section includes a distal portion and a proximal portion, the distal portion of the intermediate section being twisted in a first radial direction and the proximal portion of the intermediate section being twisted in a second radial direction opposite the first radial direction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/565,972 entitled “Bladeless optical obturator” filed on Aug. 3, 2012which is a continuation of U.S. patent application Ser. No. 13/085,194entitled “Bladeless optical obturator” filed on Apr. 12, 2011 now U.S.Pat. No. 8,267,952 which is a continuation of U.S. patent applicationSer. No. 10/956,167 entitled “Bladeless optical obturator” filed on Oct.1, 2004 now U.S. Pat. No. 7,947,058 which is continuation-in-part ofU.S. application Ser. No. 10/489,403, filed on Mar. 11, 2004, now U.S.Pat. Pat. No. 7,686,823, which is a 371 of International Application No.PCT/US02/06759, filed on Mar. 4, 2002 based on Provisional ApplicationSer. No. 60/324,613, filed on Sep. 24, 2001, and entitled “Bladelessobturator,” all of which are fully incorporated herein by reference intheir entireties. U.S. patent application Ser. No. 10/956,167 entitled“Bladeless optical obturator” filed on Oct. 1, 2004 and now U.S. Pat.No. 7,947,058 further claims priority to provisional application Ser.No. 60/508,390, filed on Oct. 3, 2003, entitled “Bladeless opticalobturator,” which is fully incorporated herein by reference in itsentirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention generally relates to trocar systems including obturatorsand, more specifically, to blunt tip obturators having hollow shafts forinsertion of optical instruments.

2. Discussion of the Prior Art

Trocar systems have been of particular advantage in facilitating lessinvasive surgery across a body wall and within a body cavity. This isparticularly true in abdominal surgery where trocars have provided aworking channel across the abdominal wall to facilitate the use ofinstruments within the abdominal cavity.

The trocar systems of the past typically included a cannula, whichprovides the working channel, and an obturator which is used to placethe cannula across the abdominal wall. The obturator is inserted intothe working channel of the cannula and then pushed through the abdominalwall with a penetration force of sufficient magnitude resulting inpenetration of the abdominal wall. Once the cannula is in place, theobturator can be removed.

Obturators have been developed with an attempt to reduce the penetrationforce of the abdominal wall. For example, sharp blades, sharp edges andpiercing points have typically been used to enable the obturator to cutor pierce its way through the abdominal wall. While the sharp blades,sharp edges and piercing points have facilitated a reduced penetrationforce, they have also caused larger trocar site defects. These trocarsite defects may have to be sutured closed resulting in increasedoperating room costs and procedural time. Moreover, once the abdominalwall has been penetrated, the sharp blades, sharp edges and piercingpoints of the obturator may still cause damage to the vessels and organsthat lie within the peritoneal cavity. For example, the blades on theobturators that serve to cut tissue during insertion may also cutvessels or puncture organs that may result in patient injury or surgicalcomplications.

In some cases, shields have been provided with the obturators in orderto sense penetration of the abdominal wall and immediately shield thesharp blades, edges or piercing points. These shielding systems aretypically complex and require some time to deploy and, as such, manyhave not been effective in protecting the vessels and organs against thesharp blades, edges or piercing points. Accordingly, there remains aneed in the art for an improved bladeless obturator that separatestissue during insertion through a body wall. Moreover, there is a needfor a transparent blunt tip obturator having a hollow shaft to enableinsertion of an optical instrument to view the insertion of theobturator through the body wall.

SUMMARY OF THE INVENTION

The invention is directed to a bladeless trocar obturator to separate ordivaricate body tissue during insertion through a body wall. The distaltip of the bladeless obturator is constructed of a transparent materialto enable visualization of tissue during the insertion of the obturatorthrough the body wall. The bladeless obturator is configured to enablethe insertion of a conventional laparoscope which typically includes animaging element and fiber optic light fibers. During use, the bladelessobturator is first inserted into and through a trocar seal and cannula.A conventional laparoscope is then inserted into the proximal end of thebladeless obturator and advanced to the distal tip of the obturator. Anendoscopic video camera is attached to the proximal end of thelaparoscope and the bladeless trocar system is then axially advanced bythe surgeon through the body wall, the surgeon can visually observe thetissue as it is being separated via a video monitor that is connected tothe endoscopic video camera.

In one aspect, the obturator of the invention comprises a shaftextending along an axis between a proximal end and a distal end; and abladeless tip disposed at the distal end of the shaft and having agenerally tapered configuration with an outer surface, the outer surfaceextending distally to a blunt point with a pair of side sections havinga common shape and being separated by at least one intermediate section,wherein each of the side sections extends from the blunt point radiallyoutwardly with progressive positions proximally along the axis, and theshaft is sized and configured to receive an optical instrument having adistal end to receive an image of the body tissue. With this aspect, thetapered configuration facilitates separation or spreading of differentlayers of the body tissue and provides proper alignment of the tipbetween the layers. The side sections include a distal portion and aproximal portion, the distal portion of the side sections being twistedradially with respect to the proximal portion of the side sections. Theintermediate section includes a distal portion and a proximal portion,the distal portion of the intermediate section being twisted in a firstradial direction and the proximal portion of the intermediate sectionbeing twisted in a second radial direction opposite the first radialdirection.

The bladeless tip can be formed from a transparent material or atranslucent material. The bladeless tip can be formed from a plasticmaterial or a glass material. The plastic material can be at least oneof polycarbonate, polyphenylsulfone, polyetherimide, acrylic, andpolyvinyl chloride. The bladeless obturator can be constructed such thatat least one of the shaft and the tip is formed from a reusable or adisposable material. The reusable material can be a metallic material oran autoclavable polymer. The bladeless tip can be generally hollow orsubstantially solid to receive the distal end of the optical instrument.The bladeless tip can also be solid. The bladeless tip can furthercomprise at least one portion that is marked differently from the restof the tip to serve as an indicator, for example, of depth as the tip isbeing inserted into the body tissue. The bladeless tip can be shaped andconfigured to receive the distal end of the optical instrument having anangled or non-angled lens. The bladeless tip can further comprise aledge to provide proper positioning of the distal end of the opticalinstrument having an angled or non-angled lens. The bladeless tip canfurther comprise a bulbous section to accommodate the distal end of theangled lens optical instrument. The bladeless tip can be further coatedor formed from a soft elastomeric material. The shaft and the tip can beconnected together by adhesive bonding, ultrasonic welding,snap-fitting, with a shrink tube, or by overmolding the tip over theshaft. The bladeless tip can further comprise a cutout section toprovide the distal end of the optical instrument with direct vision ofthe body tissue.

In another aspect of the invention, the bladeless obturator furthercomprises a lock disposed at the proximal end of the shaft tofrictionally lock the optical instrument in an axial position in theshaft. The lock operates to prevent the optical instrument from movingaxially relative to the shaft while allowing the optical instrument torotate freely about the shaft. The lock can be constructed from aplastic material including polycarbonate. The lock can be a multi-fingercollet having an inner diameter smaller than an outer diameter of theoptical instrument wherein the fingers of the collet spread open duringinsertion of the optical instrument providing frictional engagement withthe outer diameter of the optical instrument. The lock can furthercomprise a camming member to constrict the optical instrument in theaxial position relative to the shaft. The camming member may be ahorizontal or vertical camming member. In another aspect, the lock canfurther comprise a locking collar to rotationally lock the opticalinstrument. In yet another aspect, the lock can further comprise alocking nut and thread that frictionally engage the optical instrumentin the axial position relative to the shaft, or an elastomeric elementthat facilitates frictional engagement with the optical instrument inthe axial position relative to the shaft.

In another aspect of the invention, the bladeless obturator furthercomprises a cap disposed at the proximal end of the shaft. The cap mayfurther comprise a handle.

In yet another aspect of the invention, a surgical obturator adapted toseparate body tissue is disclosed comprising a shaft extending along anaxis between a proximal end and a distal end; and a bladeless tipdisposed at the distal end of the shaft having a tapered surface formingproximally into an outer surface, the outer surface including a pair ofgenerally opposed sections, wherein the outer surface has a generallygeometric shape in progressive radial cross-sections from a distalcross-section to a proximal cross-section, wherein the pair of generallyopposed sections of the outer surface appears as a pair of lines in eachof the progressive radial cross-sections, wherein at least one of thepair of lines becomes more arcuate in the progressive radialcross-sections, and wherein the shaft is sized and configured to receivean optical instrument having a distal end to receive an image of thebody tissue. With this aspect, the area of the geometric shape increasesalong the progressive radial cross-sections.

In another aspect of the invention, a surgical obturator adapted toseparate body tissue is disclosed comprising a shaft having a proximalend and a distal end; and a transparent bladeless tip disposed at thedistal end of the shaft having a tapered surface forming proximally intoan outer surface, the outer surface extending distally to a blunt point,wherein the shaft is sized and configured to receive an opticalinstrument having a distal end to receive an image of the body tissue.

In yet another aspect of the invention, an optical separator adapted toreceive an image of a body tissue and to separate the body tissue isdisclosed comprising an optical instrument having a proximal end and adistal end; and a bladeless tip removably attached at the distal end ofthe optical instrument and having a generally tapered configuration withan outer surface, the outer surface extending distally to a blunt point.

These and other features of the invention will become more apparent witha discussion of the various embodiments in reference to the associateddrawings.

DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included in and constitute a partof this specification, illustrate the embodiments of the invention and,together with the description, explain the features and principles ofthe invention. In the drawings:

FIGS. 1A and 1B illustrate side views of a trocar system including acannula with associated valve housing, and an obturator with a blunt tipextending through the working channel of the cannula to facilitateplacement across the abdominal wall;

FIG. 2 is a side elevation view of the blunt tip of the obturator of theinvention;

FIG. 3 is a side elevation view of the blunt tip taken along line 3-3 ofFIG. 2;

FIG. 4 is an end view taken along line 4-4 of FIG. 2;

FIG. 5 is a radial cross-section view taken along line 5-5 of FIG. 2;

FIG. 6 is a radial cross-section view taken along line 6-6 of FIG. 2;

FIG. 7 is a radial cross-section view taken along line 7-7 of FIG. 2;

FIG. 8 is a radial cross-section view taken along line 8-8 of FIG. 2;

FIG. 9 is a radial cross-section view taken along line 9-9 of FIG. 2;

FIG. 10 is a schematic view illustrating each of the FIGS. 4-9super-imposed to facilitate an understanding of the blunt tip and itstwisted configuration;

FIG. 11 illustrates a side view of a bladeless obturator of theinvention having a tip formed as a blunt tapered shape;

FIG. 12 illustrates a side view of a bladeless obturator of theinvention having a tip formed as a pyramidal shape;

FIG. 13 illustrates a side view of a bladeless obturator of theinvention having a fully radiused tip;

FIGS. 14 and 15 illustrate a side view and a cross-section view,respectively, of the trocar system of FIGS. 1A and 1B and furtherillustrating the insertion of a laparoscope;

FIG. 16 illustrates a side view of a bladeless obturator of theinvention having a bulbous tip;

FIG. 17 illustrates a side view of a bladeless obturator of theinvention having a tip with a cutout section;

FIG. 18 illustrates a side view of a bladeless obturator of theinvention having a shaft with a cutout section;

FIG. 19 illustrates a side view of a bladeless obturator of theinvention and a cover for the cutout section of the shaft of FIG. 18;

FIGS. 20 and 21 illustrate side views of a bladeless obturator of theinvention having a laparoscope lock;

FIGS. 22 and 23 illustrate side views of a bladeless obturator of theinvention including a cap with pistol-grip handle;

FIGS. 24 and 25 illustrate the locking mechanism between the bladelessobturator and the trocar seal of the invention;

FIGS. 26 and 27 illustrate the release mechanism between the bladelessobturator and the trocar seal of the invention;

FIG. 28 illustrates a top view of a laparoscope lock of the inventioncomprising a multiple-finger collet;

FIG. 29 illustrates an optical instrument having a transparent bladelesstip of the invention;

FIGS. 30 and 31 illustrate a top view and a side view, respectively, ofa laparoscope lock of the invention comprising a camming member;

FIGS. 32 and 33 illustrate a top view and a side view, respectively, ofa laparoscope lock of the invention comprising a clamping member;

FIGS. 34 and 35 illustrate a top view and a side view, respectively, ofa laparoscope lock of the invention comprising a locking collar; and

FIGS. 36 and 37 illustrate a top view and a side view, respectively, ofa laparoscope lock of the invention comprising a locking nut and thread.

DESCRIPTION OF THE INVENTION

A trocar system is illustrated in FIG. 1 and is designated by referencenumeral 10. This system includes a cannula 12, defining a workingchannel 14, and a valve housing 16. The system 10 also includes anobturator 18 having a shaft 21 extending along an axis 23. A handle 25is disposed at a proximal end of the shaft 21 while a blunt tip 27 isdisposed at a distal end of the shaft 21. The shaft 21 of the obturator18 is sized and configured for disposition within the working channel 14of the cannula 12. With this disposition, the obturator 18 can be placedacross a body wall such as the abdominal wall to provide the cannula 12with access across the wall and into a body cavity, such as theperitoneal or abdominal cavity. The blunt tip 27 serves to direct theobturator 18 through the abdominal wall and the peritoneum, and can beremoved with the obturator 18 once the cannula 12 is operativelydisposed with the working channel 14 extending into the abdominalcavity. The diameter of the shaft 21 can range from about 3 mm to about20 mm and is designed to fit within a trocar seal and the cannula 12.

In accordance with the present invention, the tip 27 is provided with ablunt tip configuration. The blunt tip 27 of the invention takes intoaccount the anatomical configuration of the abdominal wall with animproved structural design and method of insertion. To fully appreciatethese aspects of the invention, it is helpful to initially discuss theanatomy associated with the abdominal wall. The abdominal wall typicallyincludes a skin layer and a series of muscle layers, in addition to fatand fascia. The muscle layers are each defined by muscle fibers thatextend generally parallel to each other in a direction that is differentfor each of the layers. For example, fibers of a first muscle layer anda second muscle layer may extend in directions that are generally 90degrees off of each other.

Having noted the directional nature of the muscle fibers, it can beappreciated that such a structure may be separated or divaricated by anobturator having a blunt tip. The blunt tip may also include a twistedrectangular configuration to facilitate movement between the musclefibers and layers. That is, the blunt tip is capable of being movedgenerally parallel to and between the fibers associated with aparticular muscle layer.

As described earlier, the fibers of the muscle layers may be oriented atdifferent angles to each other such that proper alignment of the tip 27for separation of one layer may not necessarily result in properalignment for separation of the next layer. For at least this reason,the obturator 18 has a blunt tip 27 to direct the obturator 18 throughthe different layers and a rectangular configuration that is twistedslightly so that separation of a first layer begins to rotate the distalend of the blunt tip 27 into proper orientation for separation of thenext layer.

The twisted configuration of the blunt tip 27 also causes the blunt tip27 to function, for example, with the mechanical advantage of a screwthread. With this configuration, an exemplary method of placementrequires that the user grip the handle 25 of the obturator 18 and twistit about the axis 23. This twisting motion in combination with the screwconfiguration of the blunt tip 27 converts radial movement into forwardmovement along the axis 23. Thus, the user applies both a forwardlydirected force as well as a radial force to move the trocar system 10 ina forward direction.

The twisted configuration of the blunt tip 27 is most apparent in theside elevation views of FIGS. 2 and 3. In this embodiment, the blunt tip27 comprises generally of eight surfaces: two opposing surfaces 50 and52, separated by two side surfaces 54 and 56, two end surfaces 58 and59, a generally tapered surface 60 formed in surfaces 50 and 52 aroundaxis 23 and extending beyond end surfaces 58 and 59, and a blunt surface62.

The surfaces 50 and 52, side surfaces 54 and 56, and tapered surface 60generally define the cross-section of the blunt tip 27 from bluntsurface 62 to proximal end 61. This configuration can best beappreciated with reference to the cross-section views of FIGS. 4-9. InFIG. 4, the distal end of the blunt tip 27 is shown with a circle 64having the smallest circular area and a rectangle 63 having the greatestlength-to-width ratio. The rectangle 63 has a twisted, S-shapedconfiguration at end surfaces 58 and 59.

As views are taken along progressive proximal cross-sections, it can beseen that the circle 64 becomes larger and the rectangle 63 becomes lesstwisted, and the width increases relative to the length of the rectangle63. The spiral nature of the blunt tip 27 is also apparent as the circle64 and rectangle 63 move counterclockwise around the axis 23. This isperhaps best appreciated in a comparison of the circle 64, the rectangle63 and the side surfaces 54 and 56 in FIG. 6 relative to that in FIG. 5.With progressive proximal positions, the circle 64 begins to expand withincreasing circular area and the rectangle 63 begins to widen with areduction in the ratio of length to width. The long sides 63′ of therectangle 63 also tend to become more arcuate as they approach a morerounded configuration most apparent in FIGS. 8 and 9. That is, thecircle 64 and the rounded rectangle 63 become more circular withprogressive proximal positions. Furthermore, the circle 64 expands at alesser rate than the rectangle 63, which eventually absorbs the circle64 as shown in FIGS. 8 and 9. In these figures, it will also be apparentthat the rotation of the rectangle 63 reaches a most counterclockwiseposition and then begins to move clockwise. This is best illustrated inFIGS. 7-9. This back and forth rotation results from the configurationof the side surfaces 54 and 56, which in general are U-shaped as bestillustrated in FIGS. 2 and 3.

The ratio of the length to width of the rectangle 63 is dependent on theconfiguration of the side surfaces 54 and 56, which define the shortsides of the rectangle 63 as well as the configuration of the surfaces50 and 52, which define the long sides of the rectangle 63. Again withreference to FIGS. 2 and 3, it can be seen that the side surfaces 54 and56 are most narrow at the end surfaces 58 and 59. As the side surfaces54 and 56 extend proximally, they reach a maximum width near the pointof the most counterclockwise rotation, shown generally in FIG. 8, andthen reduce in width as they approach the proximal end 61. Along thissame distal to proximal path, the surfaces 50 and 52 transition from agenerally flat configuration at the end surfaces 58 and 59 to agenerally rounded configuration at the proximal end 61.

In the progressive views of FIGS. 5-7, the circle 64 is furtherdesignated with a lower case letter a, b or c, respectively; similarly,the rectangle 63 and the side surfaces 54 and 56 are further designatedwith a lower case letter a, b, c, d or e, respectively, in FIGS. 5-9. InFIG. 10, the circles 64, 64 a-64 c, the rectangles 63, 63 a-63 e and theside surfaces 54, 54 a-54 e and 56, 56 a-56 e are superimposed on theaxis 23 to show their relative sizes, shapes and angular orientations.

With a generally tapered configuration at the distal end and arectangular configuration at a distal portion of the tip, the tip 27appears much like a flathead screwdriver having a blunt tip. Moreparticularly, the tip 27 includes a tapered structure extending outwardfrom the end surfaces 58 and 59 that serves to direct the obturator 18through the tissue fibers.

In one aspect, the lengths of the end surfaces 58 and 59 may be alignedparallel with the fibers of each muscle layer. A simple back and forthtwisting motion of the blunt tip 27 tends to separate the fibers alongnatural lines of separation, opening the muscle layer to accept thelarger diameter of the cannula 12. Once the first layer is substantiallyseparated, the tapered and twisted configuration of the blunt tip 27directs and turns the rectangle 63 more into a parallel alignment withfibers in the next layer. Again, the blunt tip 27 and the twisting ordithering motion facilitates an easy separation of the fibers requiringa significantly reduced insertion force.

The invention facilitates a unique method of separating tissue and canbe applied to any object with a blunt tip and generally flat sides. Inparticular, the device of the invention can be operated by rotating inalternating clockwise and counterclockwise directions while applying adownward force. When rotating in alternating directions, the tissue ismoved apart and a larger opening is created for a profile of greatercross-sectional area to follow. This process continues safely as thedevice enters the peritoneal cavity and moves to its operative position.

When the cannula 12 is ultimately removed, the size of the opening leftin the tissue is minimal. Importantly, this opening is left with a smalldefect that does not require suturing due to a dilating effect caused bythe mere separation of fibers. Since there are no sharp blades, sharpedges or piercing points to cut tissue fibers, the healing process isshortened. It is appreciated that in other aspects of the invention, thetip of the bladeless obturator 18 can be formed as a generally taperedshape 27 a with a blunt distal end as illustrated in FIG. 11, as apyramidal shape 27 b with a blunt distal end and blunt edges asillustrated in FIG. 12, and as a fully radiused tip 27 c for insertionthrough flaccid tissue or an existing body orifice such as the urethraas illustrated in FIG. 13.

The blunt tip 27 can be formed from a translucent or a transparentmaterial. The blunt tip 27 can be formed from a plastic material or aglass material. In one aspect, the shaft 21 and the tip 27 are formedfrom a transparent polycarbonate material.

Referring to FIGS. 14 and 15, the bladeless obturator 18 of theinvention is designed to accommodate the insertion of a conventionallaparoscope 30. In particular, the shaft 21 of the bladeless obturator18 is hollow to allow for the insertion of the laparoscope 30 at anopening 32. The shaft 21 is sized and configured to allow thelaparoscope 30 to slide within proximity of the tip 27 thus providing aviewing area through the tip 27. An endoscopic video camera (not shown)is typically connected to the laparoscope 30 and this combination isconnected to a video monitor. By enabling the positioning of theconventional laparoscope 30 within the tip 27 of the bladeless obturator18, it is possible to visually observe body tissue as it is beingseparated by the trocar system 10. Visualization of body tissue as it isbeing separated by the trocar system 10 allows a surgeon to monitor theadvancement of the trocar system 10 and to avoid traumatizing vessels ororgans. For example, during a laparoscopic cholecystectomy, a trocar isusually placed through the umbilicus of the patient. The placement ofthis trocar is typically performed in a blind fashion in that thesurgeon cannot see where the tip of the trocar is as it is advancedthrough the abdominal wall and into the abdominal cavity of the patient.This results in a high degree of risk that the trocar may beinadvertently advanced too far into the abdomen of the patient resultingin trauma to vital organs and/or vessels. By providing a trocar systemwith visualization properties, this risk is diminished as the surgeon isbetter able to determine when the trocar has traversed the abdominalwall.

It is appreciated that the tip 27 may be generally hollow or it may besubstantially solid to receive the distal end of the laparoscope 30. Inanother aspect, the tip 27 may be a solid tip. The tip 27 may furthercomprise at least one portion that is marked differently from the restof the tip to serve as an indicator, for example, of depth as the tip 27is being inserted into the body tissue. The at least one portion may beopaque or marked with a different color from the rest of the tip 27.

The shaft 21 and the tip 27 of the bladeless obturator 18 canaccommodate a laparoscope with a non-angled lens, also known as a 0°laparoscope. The shaft 21 and the tip 27 can also accommodate alaparoscope with an angled lens such as a 30° laparoscope. The tip 27 isdesigned such that when either a 0° laparoscope or a 30° laparoscope isinserted therein, the lens of the laparoscope extends beyond a distaledge 36 of the cannula 12 thereby providing a clear and unobstructedview through the tip 27. The tip 27 further includes a ledge 39 thatproperly engages either the 0° laparoscope or the 30° laparoscope.

It should be noted that conventional trocars with visualizationproperties typically require a 0° laparoscope for insertion of thetrocars and a 30° laparoscope for viewing anatomical structures duringthe remainder of the laparoscopic procedure. This requires the operatingstaff to provide two laparoscopes for the laparoscopic procedure, whichincreases hospital inventory costs and surgical preparation costsrelating to cleaning and sterilization of the laparoscopes. In addition,because two laparoscopes are required for the laparoscopic procedure,there is additional operating room time required during the surgicalprocedure to transfer the endoscopic video camera from the 0°laparoscope to the 30° laparoscope which results in increased operatingroom costs for the hospital.

The bladeless obturator of the present invention provides a clearunobstructed view of body tissue through either a 0° or a 30°laparoscope, therefore obviating the need for a hospital to carry theadditional inventory required to provide two laparoscopes for eachlaparoscopic surgical procedure, and obviating the need for a hospitalto clean and sterilize a second laparoscope for each laparoscopicsurgical procedure, and obviating the need to transfer the endoscopicvideo equipment from one laparoscope to the other laparoscope duringeach laparoscopic surgical procedure. Referring to FIG. 16, the shaft 21may include a tip with a bulbous section 27 d to better accommodate thedistal end of the angled lens laparoscope. By adding the bulbous section27 d, the distal end of the angled lens laparoscope would be closer tothe tip of the obturator thereby improving visualization.

In yet another aspect of the invention, the bladeless obturator caninclude integral fiber optic light fiber elements and an integralimaging element within the shaft and the tip of the obturator. Thebladeless obturator with integral imaging means can be formed ofreusable or disposable materials.

The bladeless obturator 18 can be constructed as a single component oras multiple components such as the shaft 21 and the tip 27. If theobturator 18 is constructed as a single component, then it can be formedfrom either disposable or reusable materials. If the obturator 18 isconstructed as two or more components, then each component can be formedfrom either disposable or reusable materials as desired for a particularconfiguration. In one aspect, the obturator 18 is constructed from asingle reusable material such as metal (e.g., stainless steel) or anautoclavable polymer to facilitate re-sterilization. In another aspect,the obturator 18 is formed from a transparent steam sterilizablereusable plastic material such as polyphenylsulfone or polyetherimide.The blunt tip 27 can also be coated or otherwise constructed from a softelastomeric material. In such a case, the material can be a solidelastomer or composite elastomer/polymer.

It is further appreciated that the shaft 21 can be formed so as to bepartially or fully flexible. With this configuration, the obturator 18can be inserted through a passageway containing one or more curves ofvirtually any shape. A partially or fully flexed obturator 18 can thenbe used with a flexible cannula 12 allowing greater access to anassociated body cavity.

The obturator 18 can include a separately molded tip 27 and a molded orextruded shaft 21 with the two components, as explained above,comprising of the same material or different materials. The tip 27 canthen be attached to the shaft 21 by adhesive bonding, ultrasonicwelding, snap-fitting, or with a shrink tube. The tip 27 can also beovermolded over the shaft 21 to mechanically lock the two componentstogether. The tip 27 can be formed from a transparent material such aspolycarbonate to enable visualization while the shaft 21 can be formedfrom either an opaque material or a transparent material. The shaft 21can also be formed from a metal material.

In another aspect, the obturator 18 can include a disposable tip that isreleasably attached to a reusable shaft 21. In this aspect, a new tip 27can be used for each procedure to provide optimal visualization throughthe tip 27 of the obturator 18 during each procedure.

Referring to FIG. 17, there is shown a shaft 18 e in accordance withanother aspect of the invention including a cutout section 100 e in thetip portion 27 e that enables direct visualization of the body tissue asthe tip 27 e separates tissue fibers. By providing an obturator withcutout sections, the reflection of light from the laparoscope isminimized and the visibility of the tissue through the laparoscope isimproved as compared to a design where visualization occurs through aplastic or glass window. It is appreciated that the shaft 21 e caninclude a single or a plurality of cutouts 100 e in the tip 27 e oralong the shaft of the obturator.

Referring to FIG. 18, there is shown a shaft 21 f in accordance withanother aspect of the invention having a cutout portion 100 f along theaxial axis of the shaft 21 f. The shaft 21 f has a cross-section ofabout ½-circle to about ¾-circle and the cutout portion 100 f has across-section of about ½-circle to about ¼-circle. An advantage of thisaspect of the invention is the wall of the shaft 21 f can be a littlethicker as a result of the cutout section, which makes injection moldingof the shaft easier.

Referring to FIG. 19, there is shown a cover 102 f that can be attachedover the cutout portion 100 f of the ½-circle shaft 21 f as shown inFIG. 18. In particular, a polycarbonate cover also with a ½-circleshaped cross-section can be attached to the shaft to form a tubularcross-section. An advantage of molding the tubular shaft 21 f in twopieces is increased manufacturability of the shaft 21 f. The cover 102 fcan be attached to the shaft 21 f with an adhesive bond, an ultrasonicweld, a snap-fit, or with a shrink tube.

In another aspect, the obturator can be formed from two clam-shellcomponents each including one-half of the shaft and tip configurationalong the axial axis of the obturator. The two components can then beaffixed together using an adhesive bond, an ultrasonic weld, an outershrink tube, or a snap fit.

Referring to FIGS. 20 and 21, another feature of the bladeless obturator18 of the invention is it is designed to frictionally lock thelaparoscope 30 in place using a laparoscope lock 40, which can be formedwithin the handle 25. More specifically, the laparoscope lock 40prevents the laparoscope 30 from moving axially relative to the shaft 21of the obturator 18 during handling within the sterile field and duringinsertion through a body wall but enables the laparoscope 30 to rotatefreely relative to the shaft 21. This rotation of the lock 40 enablesthe trocar system 10 to be twisted during insertion into and through theabdominal wall while maintaining the laparoscope 30 in a fixedrotational position that provides for a stable viewing image on thevideo monitor.

The conventional obturators with visualization properties include meansfor locking the laparoscope in place but these obturators lock thelaparoscope both axially and rotationally. A drawback of theconventional devices is the viewing image on the video monitor isunstable if the trocar is twisted during insertion. More specifically,with prior art obturator laparoscope locks, if the trocar is twistedback and forth in a clockwise and counter-clockwise fashion, thelaparoscope also moves clockwise and counter-clockwise with the trocarresulting in an oscillating and disorienting viewing image on the videomonitor. The laparoscope lock 40 of the present invention improvesvisualization and enables a more precise placement of the trocar withinthe body tissue and across the body wall as compared to obturators ofthe prior art while preventing inadvertent axial movement of thelaparoscope during handling and use.

In another aspect of the invention as illustrated in FIGS. 20 and 21,the bladeless obturator 18 further comprises a cap 42 that can besnap-fitted onto the proximal end of the obturator shaft 21, after whichthe laparoscope lock 40 can be snap-fitted onto the end of the cap 42.Both the cap 42 and the lock 40 can be formed of a plastic material suchas polycarbonate. The obturator cap 42 can be provided with and withouta pistol-grip handle. The handled version of the bladeless obturatorprovides a pistol-grip to ease insertion of the trocar system asillustrated in FIGS. 22 and 23. The pistol-grip handle is designed tonest into the handle on the trocar seal to prevent excessive flexure ofthe handle during insertion of the trocar as illustrated in FIG. 23.More particularly, the handled bladeless obturator includes threecomponents comprising of an obturator shaft 21 b, an obturator cap 42 bhaving a pistol-grip handle 26 b, and a laparoscope lock 40 b, all ofwhich can be injection molded out of polycarbonate. The pistol-griphandle 26 b can be formed with two components frictionally fittedtogether with, for example, interference pins. The interference pins canbe fitted into holes in the handle 26 b to affect a frictional lockbetween the two components.

Referring to FIG. 24, the bladeless obturator 18 is designed toreleasably attach to a trocar seal 17 via two cantilever snap-fits 70 a,70 b. As the obturator 18 is inserted into the trocar seal 17 andcannula 12, the snap-fits 70 a, 70 b passively engage the trocar seal 17and serve to axially lock the obturator 18 to the trocar seal 17 andcannula 12 (FIGS. 24 and 25). To release the obturator 18 from thetrocar seal 17 and cannula 12, outboard tabs 72 a, 72 b on the obturatorcap 42 are depressed inwardly and the obturator 18 is then free to beslidably removed as illustrated in FIGS. 26 and 27. Referring back toFIGS. 20 and 21, the bladeless obturator 18 includes axial key members74 at its proximal end which are designed to mate with axial keyways onthe trocar seal 17. As the bladeless obturator 18 is inserted into thetrocar seal 17 and cannula 12, the obturator 18 is rotated slightly toalign the axial key members 74 with the axial keyways and then advanceduntil the snap-fits 70 a, 70 b engage the trocar seal 17. The axial keymembers 74 serve to rotationally lock the obturator 18 to the trocarseal 17.

Referring to FIG. 28, there is shown another embodiment of thelaparoscope lock 40 c comprising a multiple-finger collet 80 ccomprising a plurality of fingers 82 c. The multiple-finger collet 80 chas an inner diameter that is smaller than the outer diameter of thelaparoscope. The fingers 82 c of the collet 80 c spread open duringinsertion of the laparoscope providing frictional engagement with theouter diameter of the laparoscope. The laparoscope lock 40 c is free torotate on an obturator cap 42 c, and allows the laparoscope to freelyrotate relative to the shaft of the bladeless obturator.

Referring back to FIGS. 20 and 21, the obturator shaft 21 of thebladeless obturator 18 can be configured with a barb 76 at its proximalend. The barb 76 is vertically slotted to enable the shaft 21 to flexduring assembly. The obturator shaft 21 may also include a plurality ofkeys (not shown) near its proximal end. The obturator cap 42 isconfigured to axially slide over the barb 76 on the obturator shaft 21to affect a one-way snap-fit lock between the two components. Thissnap-fit prevents the removal of the obturator cap 42 from the obturatorshaft 21. The obturator cap 42 may further include keyways (not shown)that engage the keys on the obturator shaft 21 to rotationally index thecomponents together. The obturator cap 42 may further include a secondbarb (not shown) at its proximal end. The laparoscope lock 40 mayinclude a plurality of tabs (not shown) that are designed to spread andaxially slide over the second barb on the obturator cap 42 to affect aone-way snap-fit lock between the obturator cap 42 and the laparoscopelock 40. This snap-fit prevents the axial removal of the laparoscopelock 40 from the obturator cap 42. The laparoscope lock 40 is free torotate relative to the obturator cap 42.

Referring to FIG. 29, there is shown another aspect of the invention ofa laparoscope 30 a having a tip 33 a configured similar to that of thetip 27 of the bladeless obturator 18 described above, the tip 33 a beingadapted to snap-fit or frictionally engage the end of the laparoscope 30a. With this configuration, the combination of the tip 33 a and thelaparoscope 30 a serve to form an optical obturator having a blunt tip.Once the trocar is inserted and the laparoscope removed from the trocarseal and cannula, the bladeless tip 33 a can then be removed from thelaparoscope 30 a. The bladeless tip 33 a can be formed from either adisposable or reusable transparent material. The bladeless tip 33 a canbe temporarily or permanently affixed to the scope 30 a by any of theknown methods of attaching the two components together as explainedabove.

Referring to FIGS. 30 and 31, there is shown a laparoscope lock 40 d inaccordance with another embodiment of the invention including an activelock comprising a camming member 43 d. With this type of lock, thelaparoscope would first be inserted into the shaft of the obturator andthen the lock 40 d would be activated to lock the laparoscope in anaxial position relative to the shaft. The lock 40 d can either rotatefreely to enable the laparoscope to rotate freely relative to the shaftor the lock 40 d can be rotationally fixed to prevent the laparoscopefrom rotating relative to the shaft. In another aspect as illustrated inFIGS. 32 and 33, a lock 40 e can include an active lock comprising aclamping member 45 e. With this type of lock, the laparoscope wouldfirst be inserted into the shaft of the obturator and then the lockwould be activated to lock the laparoscope in an axial position relativeto the shaft. The lock 40 e can either rotate freely to enable thelaparoscope to rotate freely relative to the shaft or the lock 40 e canbe rotationally fixed to prevent the laparoscope from rotating relativeto the shaft.

Referring to FIGS. 34 and 35, there is shown a lock 40 f in accordancewith another embodiment of the invention including an active lockcomprising a locking collar 46 positioned eccentrically with respect tothe axis of the obturator so that as the locking collar 46 is turned, africtional engagement with the laparoscope is affected. The laparoscopewould first be inserted into the locking collar 46 and the shaft of theobturator, the locking collar 46 can then be turned to frictionallyengage the laparoscope. The laparoscope lock 40 f can either rotatefreely to enable the laparoscope to rotate freely relative to the shaftor the laparoscope lock 40 f can be rotationally fixed to prevent thelaparoscope from rotating relative to the shaft.

In another aspect of the invention as illustrated in FIGS. 36 and 37,there is shown a laparoscope lock 40 g including an active lockcomprising of a locking nut 48 and a thread. The threaded portion of thelock 40 g has flexible elements similar to those on a collet. Thelaparoscope would first be inserted into the threaded portion of thelock 40 g and the nut then rotated clockwise to collapse the flexibleelements to frictionally engage the laparoscope. To release thelaparoscope, the nut is rotated counter-clockwise.

In another aspect, the laparoscope lock can include a lock that includesan elastomeric element. The addition of the elastomeric element canenhance the frictional engagement with the laparoscope. An example ofsuch an elastomeric element is a silicone O-ring sized with an insidediameter smaller than the outside diameter of the laparoscope. Thelaparoscope lock can either rotate freely to enable the laparoscope torotate freely relative to the shaft or the laparoscope lock can berotationally fixed to prevent the laparoscope from rotating relative tothe shaft.

In yet another aspect, the obturator 18 can also be used as aninsufflation needle having a passageway and valve to administer carbondioxide or other insufflation gas to the peritoneal cavity. Theobturator 18 can also be used with an insufflation needle cannula inwhich case removal of the obturator 18 upon entry would allow for rapidinsufflation of the peritoneal cavity.

In another aspect of the invention, the bladeless obturator can beformed with a 2-3 mm outer diameter and with a small thru-hole at itsdistal end. The bladeless obturator can be used in conjunction with aminiaturized laparoscope to provide initial access into a hollow bodycavity. Once access is obtained, the laparoscope can be removed from thebladeless obturator and an insufflation gas such as carbon dioxide canbe dispensed through the obturator into the hollow body cavity. Thebladeless obturator can also include holes in the tip portion to enhancethe flow of insufflation gases though the obturator. More particularly,the bladeless obturator can be formed with a 2-3 mm outer diameter andused in conjunction with a miniaturized laparoscope to provide initialaccess into a hollow body cavity. After access is obtained, thebladeless obturator can be removed from the trocar cannula and aninsufflation gas such as carbon dioxide can be dispensed though thecannula and into the hollow body cavity.

It will be understood that many modifications can be made to thedisclosed embodiments without departing from the spirit and scope of theinvention. For example, various sizes of the surgical device arecontemplated as well as various types of constructions and materials. Itwill also be apparent that many modifications can be made to theconfiguration of parts as well as their interaction. For these reasons,the above description should not be construed as limiting the invention,but should be interpreted as merely exemplary of preferred embodiments.

We claim:
 1. A surgical access device comprising: a tissue separatingobturator comprising: an elongate shaft extending along a longitudinalaxis and defining a first lumen between an open proximal end and adistal end; and a transparent distal tip with an inner surface and anouter surface adapted for penetrating tissue; the distal tip disposed atthe distal end of the elongate shaft; at least part of the distal tiphaving a generally tapered configuration; wherein the first lumen issized and configured to receive an optical instrument having a distalend adapted to receive an image and the distal tip being adapted topermit passage of an image; and a lock disposed at the proximal end ofthe elongate shaft configured to allow the optical instrument to rotatefreely inside and relative to the elongate shaft of the obturator whilerestraining the optical instrument inserted into the first lumen frommoving axially relative to the obturator; wherein the lock has an innerdiameter that is smaller than the first lumen diameter and in directcontact with an inserted optical instrument and frictionally engagingthe optical instrument to prevent movement of the optical instrument inthe axial direction relative to the shaft.
 2. The surgical access deviceof claim 1 wherein the lock includes a caming member configured to moveto constrict the optical instrument in the axial position relative tothe obturator.
 3. The surgical access device of claim 1 wherein the lockincludes a rotatable locking nut and threaded portion; the lock furtherhaving flexible elements configured to move into frictional engagementwith an optical instrument disposed inside the first lumen tofrictionally lock the optical instrument relative to the obturator whenthe nut is rotated relative to the shaft in one direction and unlock theoptical instrument relative to the obturator when the nut is rotatedrelative to the shaft in the opposite direction.
 4. The surgical accessdevice of claim 1 wherein the lock includes an elastomeric element thatfrictionally engages with the optical instrument.
 5. The surgical accessdevice of claim 1 wherein the lock rotates relative to the elongateshaft.
 6. The surgical access device of claim 5 wherein the rotatablelock includes a fixed position in which it does not rotate relative tothe shaft.
 7. The surgical access device of claim 1 wherein the lockrotates with respect to the elongate shaft and the optical instrumentinserted into the first lumen is fixed with respect to the lock.
 8. Thesurgical access device of claim 1 wherein the lock is configured tofrictionally engage with the outer diameter of the optical instrumentinserted into the first lumen to minimize movement of the opticalinstrument in the axial direction relative to the obturator.
 9. Thesurgical access device of claim 1 further including a cannula comprisingan elongate shaft extending along a longitudinal axis and defining asecond lumen between an open proximal end and an open distal end; thecannula being configured to receive the obturator inside the secondlumen and to connect to the obturator such that the obturator does notmove axially or rotationally relative to the cannula.
 10. The surgicalaccess device of claim 9 further including an obturator cap connected tothe proximal end of the obturator; wherein the obturator cap isconfigured to removably connect to the proximal end of the cannula. 11.The surgical access device of claim 10 wherein the lock is connected tothe obturator cap.
 12. The surgical access device of claim 1 furtherincluding a small hole in the distal tip configured for deliveringinsufflation gases through the obturator and out the small hole.
 13. Thesurgical access device of claim 1 wherein the lock is connected to theobturator and configured such that the lock is free to rotate relativeto the elongate shaft and the optical instrument inserted into the firstlumen rotates with the lock.
 14. The surgical access device of claim 1wherein the lock is configured to enable the elongate shaft to betwisted in a back and forth motion while maintaining the opticalinstrument in a fixed rotational position to provide for a stableviewing image via the optical instrument.
 15. The surgical access deviceof claim 1 wherein the lock is made of elastomeric material.
 16. Thesurgical access device of claim 1 wherein the lock comprises a collar.17. The surgical access device of claim 1 wherein the lock furtherincludes flexible elements configured to move into frictional engagementwith an optical instrument disposed inside the first lumen tofrictionally restrain the optical instrument relative to the obturator.18. The surgical access device of claim 1 wherein the lock includes acircular central opening coaxial with the first lumen and fingersextending into the first lumen that are configured to spread open duringinsertion of the optical instrument providing frictional engagement withthe outer diameter of the optical instrument.
 19. The surgical accessdevice of claim 1 wherein the lock includes an O-ring.